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Lighting Intervention to Improve Sleep

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Mount Sinai Health System

Status

Completed

Conditions

Parkinson Disease
Sleep Disturbance

Treatments

Device: Actigraph
Device: Tailored Lighting Intervention (LIT)

Study type

Interventional

Funder types

Other

Identifiers

NCT05757414
STUDY-19-00185

Details and patient eligibility

About

50 participants with Parkinson's disease will be recruited to complete actigraphy studies to assess sleep disturbances. For this, participants will wear an Actigraph for seven days. Thirty of these participants with sleep disturbance, will go on to receive a tailored lighting intervention (TLI) to assess the effect on sleep, fatigue, and circadian entrainment via urinary melatonin levels.

Full description

Participants will undergo one week of baseline data collection using the actigraph and light meter and one night of an overnight urine collection. At the completion of the baseline week, the lighting intervention will be installed in the participants home. Participants will be exposed to the lighting intervention for 2 hours each morning after awakening for 4 weeks. During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days and collect one overnight urine sample. Participants will complete questionnaires before and after the intervention to further assess its effects.

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of Parkinson's disease and
  • Difficulties with sleep or cognition

Exclusion criteria

  • There is no exclusion criteria

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

57 participants in 1 patient group

Tailored Lighting intervention (TLI)
Experimental group
Description:
The TLI will be performed for 2 hours each day over a 4-week period. During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days
Treatment:
Device: Tailored Lighting Intervention (LIT)
Device: Actigraph

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Maya Rawal

Data sourced from clinicaltrials.gov

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